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Triazolam

Triazolam tablets, USP CIV

Approved
Approval ID

ce6ddb53-89ca-4edf-a519-553d34ce7938

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Nov 7, 2017

Manufacturers
FDA

Unit Dose Services

DUNS: 831995316

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

triazolam

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code50436-3718
Application NumberNDA017892
Product Classification
M
Marketing Category
C73605
G
Generic Name
triazolam
Product Specifications
Route of AdministrationORAL
Effective DateAugust 16, 2017
FDA Product Classification

INGREDIENTS (9)

POWDERED CELLULOSEInactive
Code: SMD1X3XO9M
Classification: IACT
STARCH, CORNInactive
Code: O8232NY3SJ
Classification: IACT
TRIAZOLAMActive
Quantity: 0.25 mg in 1 1
Code: 1HM943223R
Classification: ACTIB
DOCUSATE SODIUMInactive
Code: F05Q2T2JA0
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
FD&C BLUE NO. 2Inactive
Code: L06K8R7DQK
Classification: IACT
LACTOSE, UNSPECIFIED FORMInactive
Code: J2B2A4N98G
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
SODIUM BENZOATEInactive
Code: OJ245FE5EU
Classification: IACT

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Triazolam - FDA Drug Approval Details